Announcement • Aug 14
Eupraxia Pharmaceuticals Reports Symptom Response Data From Ongoing Phase 1b/2a RESOLVE Trial Including New Data On Odynophagia In Eosinophilic Esophagitis Patients
Eupraxia Pharmaceuticals Inc. announced positive results from a new analysis of the RESOLVE study examining the effect of EP-104GI on symptom severity, including for the first time an analysis of the effect of EP-104GI on odynophagia (pain when swallowing). The number of patients experiencing moderate to severe odynophagia (pain swallowing) in the cohorts analyzed (Cohorts 7-9) was reduced from 62% at baseline to 25% from 24 through to 52 weeks post treatment. In the same analysis, 23% of patients reported severe odynophagia at baseline; and no patients reported severe odynophagia at the 24 and 52 weeks timepoints. The number of patients experiencing moderate to severe dysphagia (difficulty swallowing) in Cohorts 7-9 was reduced from 77% at baseline to 25% at 24 and 52 weeks post treatment. At baseline 31% of patients in Cohorts 7-9 had severe dysphagia; no patients had severe dysphagia at 24 and 52 weeks post treatment. EP-104GI continues to be well tolerated by patients receiving the drug. There have been over 130 patients treated in RESOLVE with EP-104GI or placebo (more than 2,000 individual injection sites) with no reported treatment-emergent or procedure related Serious Adverse Events (“SAEs”). Patients in the RESOLVE trial were asked to grade the degree of odynophagia (pain whilst swallowing) on an 11-point scale (0 = no pain, 10 = most severe pain) over the seven previous days. Measurements were recorded at baseline and at weeks 2, 4, 8, 12, 24, 36 and 52 following dosing with EP-104GI. Symptom severity was graded as most severe (score of 10), severe (scores of 7-9), moderate (scores of 4-6), mild (scores of 1-3) or none (score of 0). An analysis of the distribution of severity of symptom score was performed for the patients that received 20 injections of EP-104GI (Cohorts 7 to 9, receiving a total dose ranging from 80 mg to 160 mg in 20 injections). At baseline 62% of the EoE patients reported either moderate or severe odynophagia (n=13). At 2, 4, 8 and 12 weeks post treatment, 31% of patients reported moderate or severe odynophagia (n=13). At 24, 36 and 52 weeks, 25% of patients reported moderate or severe odynophagia (n = 12,12 and 8 respectively). At baseline, 15% of patients recorded no odynophagia, at 52 weeks, 50% of patients recorded no odynophagia. Patients in the RESOLVE trial were asked to grade the degree of dysphagia (difficulty swallowing) on an 11-point scale (0 = no troubles to swallow, 10 = most severe troubles to swallow) over the seven previous days. Measurements were recorded at baseline and at weeks 2, 4, 8, 12, 24, 36 and 52 following dosing with EP-104GI. Symptom severity was graded as most severe (score of 10), severe (scores of 7-9), moderate (scores of 4-6), mild (scores of 1-3) or none (score of 0). An analysis of the distribution of severity of symptom score was performed for the patients that received 20 injections of EP-104GI (Cohorts 7-9, receiving a total dose ranging from 80 mg to 160 mg). At baseline 77% of the EoE patients reported moderate or severe dysphagia (n=13). At 12 weeks post treatment, 54% of patients reported moderate or severe dysphagia (n=13). At 24 and 52 weeks, only 25% of patients reported moderate or severe dysphagia (n = 12 and 8 respectively). The Phase 1b/2a part of the RESOLVE trial is a multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with a history of confirmed active EoE. The treatment is administered as a single dose via 4 to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Patients were followed for up to 24 weeks in Cohorts 1-4 (4x1mg, 8x1mg, 8x2.5mg and 12x2.5mg) or 52 weeks in Cohorts 5-9 (12x4mg, 16x4mg, 20x4mg, 20x6mg and 20x8mg). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in the coming months. The Phase 2b part of the RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120mg (20x6mg) and 160mg (20x8mg) doses. The interim data from the Phase 2b part of the RESOLVE trial is expected in Fourth Quarter 2026.
